EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)

Available from:

BETTER LIVING BRANDS, LLC

Administration route:

AURICULAR (OTIC)

Prescription type:

OTC DRUG

Therapeutic indications:

Earwax removal aid For occasional use as an aid to soften, loosen and remove excessive ear wax

Authorization status:

OTC monograph final

Summary of Product characteristics

EAR WAX REMOVAL AID DROPS- CARBAMIDE PEROXIDE LIQUID
BETTER LIVING BRANDS, LLC
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EAR WAX REMOVAL AID DROPS
_DRUG FACTS_
_ACTIVE INGREDIENT_
Carbamide peroxide 6.5%
_PURPOSE_
Earwax removal aid
_USES_
For occasional use as an aid to soften, loosen and remove excessive
ear wax
_WARNINGS_
ASK A DOCTOR BEFORE USE
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WHEN USING THIS PRODUCT
avoid contact with the eyes
STOP USE AND ASK A DOCTOR IF
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KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222)
right away.
_DIRECTIONS_
FOR USE IN THE EAR ONLY.
if you have ear drainage or discharge
ear pain
irritation or rash in the ear
dizziness
an injury or perforation (hole) of the eardrum
recently had ear surgery
you need to use for more than four days
excessive ear wax remains after use this product
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CHILDREN UNDER 12 YEARS OF AGE: consult a doctor.
_OTHER INFORMATION_
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_INACTIVE INGREDIENTS_
adipic acid, anhydrous glycerin, polysorbate 80
_QUESTIONS? 1-866-467-2748_
PRINCIPAL DISPLAY PANEL
*Compare to the active ingredient in Debrox
Drops
NDC 21130-793-15
EAR WAX REMOVAL AID DROPS
Carbamide Peroxide 6.5%
Ear Wax Removal Aid
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NET WT 0.5 FL OZ (15 mL)
TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN
DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
ADULTS AND CHILDREN OVER 12 YEARS OF AGE:
tilt head sideways
place 5 to 10 drops into ear canal.
tip of applicator should not enter ear canal.
keep drops in ear for several minutes by keeping head tilted or
placing cotton in the
ear.
use twice daily for up to 4 days if needed, or as directed by a
doctor.
any wax remaining after treatment may be removed by gently flushing
the ear with
warm water, using a soft rubber bulb ear syringe.
store at room temperature
avoid exposing bottle to excessive heat and direct sunlight
store bottle in the outer carton
product foams on contact with earwax due to release of oxygen. There
may be an